Cholinergic FunctionNCT01379001
Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
A study testing Scopolamine and Donepezil in people with Cholinergic Function, run by Hebrew SeniorLife.
Trial summary
This research study will look at how medications affect the pattern of blood flow in the brain. This study will use a special type of MRI (magnetic resonance imaging) scan called perfusion MRI to make measurements of cerebral (brain) blood flow. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholinergic Function
- What is being tested?
- Scopolamine and Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- Any neurological condition, such as brain tumor, history of stroke, seizure disorder, attention deficit disorder, normal pressure hydrocephalus, dementia, traumatic brain injury
- Any major medical conditions, such a cancer, diabetes, glaucoma, prostate disease, uncontrolled hypertension
- antihistamine use
- tricyclic antidepressant use
- presence of metal in body, including pacemaker, defibrillator, neurostimulator, metal implants, or foreign metal objects such as bullets or shrapnel.
- anxiety or panic disorder
- history of claustrophobia
- pregnancy
About this study
This research study will look at how medications affect the pattern of blood flow in the brain. This study will use a special type of MRI (magnetic resonance imaging) scan called perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive testing will also be obtained, and correlated with the blood flow patterns in the brain.
Read the detailed description
Project Summary: This research project will investigate the value of combined pharmacologic manipulation and arterial spin-labeled perfusion MRI (pharmacologic ASL-pMRI) as an in vivo probe of cholinergic function. Methods to investigate cholinergic function in vivo are needed to better understand the role of acetylcholine in the physiology of the cerebral cortex, and in cognitive processes in health and in disease states. In this study, pharmacologic ASL-pMRI will be used to characterize the normal cerebral perfusion response to cholinergic manipulation in young healthy subjects. Cognitive measures will also be obtained and correlated with cerebral perfusion changes. Pharmacologic ASL-pMRI and cognitive testing will then be used to study how the cholinergic response is altered with normal aging and in delirium
- Conditions
- Cholinergic Function
- Being tested
- Scopolamine, Placebo, Donepezil
- Keywords
- cholinergic function, aging, pharmacologic MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)
PlaceboDrug
IM or PO placebo
DonepezilDrug
Also called Aricept
donepezil 5mg PO x 1
| Study group | Role | What they receive |
|---|---|---|
| Young | Experimental | Young healthy controls, aged 21-35 Receives: Drug: Scopolamine; Drug: Placebo |
| Older | Experimental | Older healthy controls, aged 65-80 Receives: Drug: Scopolamine; Drug: Placebo; Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI
Measured: 3 hours
Secondary outcomes (1)
cognitive performance
participants will undergo cognitive testing following drug administration and MRI acquisition
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJul 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholinergic FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Fong, Hebrew SeniorLife
- Investigators
- Tamara Fong, MD, Principal investigator, Hebrew Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379001
- Sponsor's protocol ID
- K23AG031320
- Status last verified
- Jan 2013
- First submitted
- 21 Jun 2011
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
- ClinicalTrials.gov ID
- NCT01379001
- Acronym / sponsor ID
- K23AG031320
- Conditions
- Cholinergic Function
- Keywords
- cholinergic function, aging, pharmacologic MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will look at how medications affect the pattern of blood flow in the brain. This study will use a special type of MRI (magnetic resonance imaging) scan called perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive testing will also be obtained, and correlated with the blood flow patterns in the brain.
Detailed description
Project Summary: This research project will investigate the value of combined pharmacologic manipulation and arterial spin-labeled perfusion MRI (pharmacologic ASL-pMRI) as an in vivo probe of cholinergic function. Methods to investigate cholinergic function in vivo are needed to better understand the role of acetylcholine in the physiology of the cerebral cortex, and in cognitive processes in health and in disease states. In this study, pharmacologic ASL-pMRI will be used to characterize the normal cerebral perfusion response to cholinergic manipulation in young healthy subjects. Cognitive measures will also be obtained and correlated with cerebral perfusion changes. Pharmacologic ASL-pMRI and cognitive testing will then be used to study how the cholinergic response is altered with normal aging and in delirium
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | Experimental | Drug: Scopolamine, Drug: PlaceboYoung healthy controls, aged 21-35 |
| Older | Experimental | Drug: Scopolamine, Drug: Placebo, Drug: DonepezilOlder healthy controls, aged 65-80 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (8 listed)
- Any neurological condition, such as brain tumor, history of stroke, seizure disorder, attention deficit disorder, normal pressure hydrocephalus, dementia, traumatic brain injury
- Any major medical conditions, such a cancer, diabetes, glaucoma, prostate disease, uncontrolled hypertension
- antihistamine use
- tricyclic antidepressant use
- presence of metal in body, including pacemaker, defibrillator, neurostimulator, metal implants, or foreign metal objects such as bullets or shrapnel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScopolamineScopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg) | Drug | Older, Young |
| PlaceboIM or PO placebo | Drug | Older, Young |
| DonepezilAlso: Ariceptdonepezil 5mg PO x 1 | Drug | Older |
Primary outcome
Cerebral blood flow
Time frame: 3 hours
cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI
1 secondary outcome
cognitive performance
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Related trials for Cholinergic Function
RecruitingObservational study
Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Fong, MD principal investigator
Hebrew Rehabilitation Center
Questions about this trial
What is this clinical trial studying?
A study testing Scopolamine and Donepezil in people with Cholinergic Function, run by Hebrew SeniorLife.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.